Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia
NCT ID: NCT07076641
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
76 participants
INTERVENTIONAL
2026-01-31
2027-07-30
Brief Summary
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Detailed Description
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The study corresponds to a clinical trial of a medicinal product in compliance with Regulation (EU) n°536/2014.
The study population is composed of adult patients receiving morphine spinal anesthesia for major laparotomy surgery and who have signed an informed consent form.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LIDOCAINE Intravenous electric syringe
Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision.
Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
rachi morphine anesthesia
Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
laparotomy
major digestive or abdominal surgery by laparotomy
Lidocaine IV
KABI 20 mg/mL solution for injection (ready-to-use ampoule, no dilution). Each ml of solution contains 20 mg lidocaine hydrochloride (monohydrate form), corresponding to 16.22 mg lidocaine.
MORPHINE
The auxiliary drug on which both experimental strategies are based is MORPHINE: Morphine hydrochloride AGUETTANT 0.1 mg/mL Solution for injection (ready-to-use ampoule) for rachi anesthesia.
PLACEBO Intravenous electric syringe
Induction bolus 1.5 mg/kg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision.
Maintenance 1.5 mg/kg/h until end of care / discharge from the intensive care unit (reduced to 1 mg/kg/h in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.
rachi morphine anesthesia
Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
laparotomy
major digestive or abdominal surgery by laparotomy
Placebo
Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
MORPHINE
The auxiliary drug on which both experimental strategies are based is MORPHINE: Morphine hydrochloride AGUETTANT 0.1 mg/mL Solution for injection (ready-to-use ampoule) for rachi anesthesia.
Interventions
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rachi morphine anesthesia
Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.
laparotomy
major digestive or abdominal surgery by laparotomy
Lidocaine IV
KABI 20 mg/mL solution for injection (ready-to-use ampoule, no dilution). Each ml of solution contains 20 mg lidocaine hydrochloride (monohydrate form), corresponding to 16.22 mg lidocaine.
Placebo
Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.
MORPHINE
The auxiliary drug on which both experimental strategies are based is MORPHINE: Morphine hydrochloride AGUETTANT 0.1 mg/mL Solution for injection (ready-to-use ampoule) for rachi anesthesia.
Eligibility Criteria
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Inclusion Criteria
* Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynecological, esophageal, gastric, duodenal, small intestine...);
* Scheduled surgery;
* Laparotomy;
* Patient in agreement with morphine rachi anesthesia;
* Social security affiliation;
* Signed informed consent.
Exclusion Criteria
* Contraindication to non-steroidal anti-inflammatory drugs: history of gastro duodenal ulcer, renal failure from stage 3 A or higher;
* History of bradycardia and/or known conduction disorder (atrioventricular block) / Pacemaker ;
* Unstable coronary ;
* Myocardial infarction \<6 months;
* Severe cardiocirculatory insufficiency;
* Severe hepatic insufficiency;
* Allergy to morphine ;
* Allergy to lidocaine;
* Rhythm disorders at risk of sudden death (e.g. Brugada syndrome);
* Flecaine as usual treatment;
* Chronic pain with level II or III analgesics;
* Gabapentinoids: pregabalin (Lyrica), gabapentin;
* Drug addiction and substitute drugs;
* Epileptic disorders ;
* Myasthenia gravis;
* Creatinine clearance below 10 mL/min;
* Hypokalemia, hypoxia or acid-base disorders;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Inability to understand study information (due to linguistic, psychological, cognitive or literacy problems);
* Women who are or may become pregnant\* (of childbearing age, without effective contraception) or who are breast-feeding;
* Patient deprived of liberty, under guardianship or unable to give consent.
18 Years
ALL
No
Sponsors
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Euraxi Pharma
INDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Hôpital Privé Jean Mermoz
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-521206-18-00
Identifier Type: -
Identifier Source: org_study_id
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